Device recall
Z-0627-2011: Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0627-2011 |
|---|---|
| Recall event | 56716 |
| Product | Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50%… |
| Product code | NJE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2010 |
| FEI number | 2939204 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database